FDA Approves Eli Lilly's Zepbound for Obstructive Sleep Apnea

By Bhanvi Satija

(Reuters) – The U.S. Food and Drug Administration (FDA) approved Eli Lilly's weight-loss treatment, Zepbound, for obstructive sleep apnea, marking the first drug approved to directly treat this common sleeping disorder.

The approval covers adults with moderate to severe obstructive sleep apnea who are also obese, potentially expanding the patient market for Eli Lilly as demand for Zepbound rises. This could help the company with commercial insurers and employers who were previously hesitant to cover the expensive drug.

Following the announcement, shares of the Indianapolis-based company rose by 1.14% in after-market trading.

Obstructive sleep apnea occurs when patients stop breathing momentarily during sleep, disrupting the sleep cycle and leading to long-term health issues like heart diseases, affecting around one billion people globally. Julie Flygare, CEO of Project Sleep, emphasized that this condition is often underestimated, being dismissed as mere snoring.

Common treatments for sleep apnea include CPAP machines, surgery, and weight loss. Zepbound, chemically known as tirzepatide, belongs to a group called GLP-1 agonists that Eli Lilly shares with its diabetes drug, Mounjaro. Initially created for type 2 diabetes, these drugs help reduce food cravings and slow gastric emptying.

Eli Lilly and Danish competitor Novo Nordisk are investigating other potential health benefits for their blockbuster obesity drugs. The FDA's approval followed data from two trials with 469 participants, revealing that Zepbound alleviated breathing issues in patients with sleep apnea, resolving the disorder in up to 52% of them and improving related biomarkers like low blood oxygen and blood pressure.

Currently, Medicare does not cover weight-loss treatments for adults 65 and older or those with disabilities, although there’s a proposal from the Biden administration to broaden this coverage. If approved by President-elect Donald Trump's administration, the changes would take effect in 2026. Medicare recently began covering Novo Nordisk's Wegovy after its approval for lowering heart attack and stroke risks in March.